A Phase I, Placebo-Controlled, Dose-Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Thalidomide in Subjects With HIV-1 Infection

Inclusion Criteria

Inclusion Criteria

Concurrent Medication:

Allowed for occasional use (chronic use is permitted only if clinician deems that
medication can be discontinued in the event of overlapping toxicity):

- CNS active agents, such as alcohol, narcotics (i.e., morphine, codeine, meperidine),
barbiturates, benzodiazepines, tricyclic antidepressants, phenothiazines, sedating
antihistamines, or over-the-counter sleeping aids.

Patients must have:

- HIV infection.

- CD4 count 200 - 500 cells/mm3.

- No active opportunistic infection requiring systemic therapy within the past 14 days.

- NOTE: Women must be post-menopausal or provide written documentation of surgical
sterilization, and sexually active men must use a barrier method of contraception,
beginning 4 weeks prior to study entry and continuing until 4 weeks following end of
treatment.

PER AMENDMENT 8/2/96:

- Been on stable licensed antiretroviral treatment for 60 days prior to study entry or
must not have received any antiretroviral medications for 60 days prior to study
entry.

Prior Medication:

Required:

- Patients must have been on stable licensed antiretroviral treatment for 60 days prior
to study entry or must not have received any antiretroviral medications for 60 days
prior to study entry.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

- Malignancy requiring chemotherapy.

- Grade 2 or worse peripheral neuropathy.

- Medical condition that would interfere with evaluation of patient.

Concurrent Medication:

Excluded in all patients:

- Didanosine ( ddI ).

- Zalcitabine ( ddC ).

- Stavudine ( d4T ).

- Other immunologically active agents.

- Systemic cytotoxic chemotherapy.

Excluded in all patients unless taken only occasionally or unless medication could be
stopped in the event of overlapping toxicity:

- CNS active agents, such as alcohol, narcotics (i.e., morphine, codeine, meperidine),
barbiturates, benzodiazepines, tricyclic antidepressants, phenothiazines, sedating
antihistamines, or over-the-counter sleeping aids.

Patients with the following prior conditions are excluded:

- History of active tuberculosis within 3 months prior to study entry.

- History of intolerance to thalidomide such as fever, rash, or neuropathy.

Prior Medication:

Excluded within 14 days prior to study entry:

- Systemic chemotherapy.

Excluded within 30 days prior to study entry:

- Topical, oral, and systemic corticosteroids.

- Pentoxifylline.

- Interferons.

- Interleukins.

- Cimetidines.

- Acetylcysteine or other glutathione depleting agents.

- Other putative immunomodulatory agents such as thymosin alpha 1, thymopentin,
isoprinosine, ditiocarb sodium, ampligen, and immune globulin.

PER AMENDMENT 8/2/96:

Excluded within 60 days prior to study entry:

- Therapy with investigational antiretroviral medications.